ALN-ANG3 + Evinacumab for Diabetic Kidney Disease
(ANCHOR-POC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two experimental drugs, ALN-ANG3 and evinacumab, to determine their safety and effectiveness for people with diabetic kidney disease. Researchers aim to learn about any side effects and how the drugs move through the body. Participants with type 2 diabetes and kidney problems affecting daily life might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ALN-ANG3 and evinacumab have been generally safe in earlier studies. ALN-ANG3 is still under investigation to further assess its safety and effectiveness. Participants in past studies have not reported major safety issues, but detailed safety information continues to be gathered.
For evinacumab, studies have found it to be generally well-tolerated. Previous research used it to treat high cholesterol, and patients did not experience significant side effects. Notably, the FDA has approved evinacumab for other conditions, indicating a certain level of safety.
Overall, while both treatments are still under study for use in diabetic kidney disease, existing research suggests they are generally well-tolerated by patients. However, more information is needed to fully understand any possible side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ALN-ANG3 and evinacumab for diabetic kidney disease because these treatments target underlying issues differently than current options like ACE inhibitors or ARBs, which mainly control blood pressure. ALN-ANG3 works by inhibiting a protein involved in lipid metabolism, potentially addressing the disease's root causes by reducing harmful lipid levels. Evinacumab is an antibody that lowers bad cholesterol by targeting a protein called angiopoietin-like 3, which could provide additional benefits for kidney function. These novel approaches could offer new hope for patients by not just managing symptoms but also slowing the disease's progression.
What evidence suggests that this trial's treatments could be effective for diabetic kidney disease?
Research has shown that ALN-ANG3, which targets the protein ANGPTL3, may help manage kidney diseases related to fat issues. Studies have found that blocking ANGPTL3 can benefit conditions like diabetic kidney disease. In this trial, some participants will receive ALN-ANG3 combined with Evinacumab, another promising treatment. Past studies demonstrated that Evinacumab lowers bad cholesterol (LDL) by 45.5%. Lowering cholesterol is important because it can help prevent kidney damage. Together, these drugs offer hope for treating diabetic kidney disease by addressing underlying fat problems.13456
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
Adults with type 2 diabetes and diabetic kidney disease can join this trial. They must be managing their diabetes through medication or lifestyle changes, have an HbA1c level between 6.5 to 10%, eGFR of 30 to 90 mL/min/1.73 m^2, and a specific range of albumin in their urine (UACR of 500 to 5000 mg/g).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either ALN-ANG3, evinacumab, or placebo to assess safety and efficacy
Pharmacokinetics
Blood samples are taken to measure the concentration of the study drugs at different times
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ALN-ANG3
- Evinacumab
Trial Overview
The trial is testing the safety and effectiveness of two experimental drugs: ALN-ANG3 and evinacumab for treating diabetic kidney disease. Participants will receive either one of these drugs or a placebo while researchers monitor drug levels in the blood and observe outcomes.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
NCT07271186 | Study to Assess the Effects of Angiopoietin ...
Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease (ANCHOR-POC).
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theglobeandmail.com/investing/markets/stocks/REGN/pressreleases/36627852/regeneron-initiates-promising-phase-2-study-on-diabetic-kidney-disease/Regeneron Initiates Promising Phase 2 Study on Diabetic ...
The study aims to evaluate the safety and effectiveness of ANGPTL3 inhibitors, specifically ALN-ANG3 and evinacumab, in treating diabetic kidney ...
ALN-ANG3 - Drug Targets, Indications, Patents
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects ...
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